Early Phase 1 Parkinson's Disease Trial, Recruiting NCT07640542 Sponsor: MODAG GmbH Condition: Parkinson's Disease
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Early Phase 1 Parkinson's Disease Trial, Recruiting

NCT07640542
Recruiting Early Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with Multiple System Atrophy (MSA) meeting two specific sets of diagnostic standards (from 2008 and 2022), people diagnosed with Parkinson's Disease (PD) meeting a specific 2015 diagnostic standard, or healthy individuals who are a similar age to the patient groups.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose routine blood or lab test results show significant abnormalities, or who have a serious unstable medical condition rated above a certain severity level (confirm with trial site).
  • People who have a significant illness or condition that the trial doctor believes would interfere with memory and thinking tests or with completing trial procedures.
  • People whose kidneys or liver are not functioning well enough, as determined by the trial doctor.
  • People who have a known allergy or sensitivity to the ingredients in the PET scan imaging agent used in this trial (called [11C]MODAG-005 injection).
  • People who have a known allergy or sensitivity to the ingredients in the study drug capsules (called anle138b or Emrusolmin).
  • People who have taken part in another clinical trial involving an experimental drug within the past 3 months before the screening visit.
  • People who have donated blood within 7 days before joining the trial.
  • People who are pregnant, breastfeeding, or planning to become pregnant, as well as women of childbearing age or men whose female partners could become pregnant who are not willing to use effective contraception throughout the trial and for 90 days after each PET/CT scan.
  • People whose veins are not suitable for repeated blood draws.
  • People for whom taking blood samples or placing an arterial line would be unsafe or not possible — for example, due to allergy to local anaesthetics, poor circulation in the limbs, a condition called Raynaud's phenomenon, abnormal blood clotting results, or failed circulation tests in both arms (note: if only the circulation test is abnormal, those people may still be able to take part in other parts of the trial — confirm with trial site).
  • People whose MRI scan shows certain brain abnormalities, such as signs of stroke, infection, tumours, fluid build-up, or other significant brain conditions — though some changes expected in PD or MSA patients will not automatically lead to exclusion (confirm with trial site).
  • People who have certain medical implants that are not safe for MRI — such as pacemakers, defibrillators, insulin pumps, cochlear implants, metal fragments in the eye, brain stimulators, or brain aneurysm clips — or people who experience severe anxiety in enclosed spaces (claustrophobia) during MRI.
  • People who are unwilling or unable to follow the trial procedures.
  • People whose liver-related blood test results (specifically GPT, GOT, and bilirubin) are above the normal range.
  • People whose kidney-related blood test results are outside the normal range (specifically creatinine and BUN above normal, or urine albumin-creatinine ratio below normal).
  • People whose blood pressure or heart rate falls outside the accepted ranges for the trial (systolic blood pressure below 90 or above 140 mmHg; diastolic blood pressure below 45 or above 90 mmHg; heart rate below 50 or above 95 beats per minute).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: +49-6734-9622-8000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
MODAG GmbH
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 July 2027

Primary endpoints

Safety and Tolerability; Safety and tolerability; Safety and tolerability; Safety and tolerability; Safety and tolerability; Safety and tolerability; Safety and tolerability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov